12 Week Open, Non-Comparative Switch Study Of Oral Ziprazidone In Previously Treated Schizophrenic Patients

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NCT00159757

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Study Location
Pfizer Investigational Site
Budapest, , , Hungary
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Contact
1-800-718-1021
[email protected]
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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- confirmed diagnosis of schizophrenia according to DSM-IV-IV from patient's medical files

- subjects with current treatment with typical or atypical neuroleptics which should be changed

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- patients with significant cardiovascular illness (recent acute myocardial infarction,
uncompensated heart failure, cardiac arrhythmia)


- in the patients' history clinically significant ECG abnormalities particularly
prolongation of QT interval of more than 500 ms

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Advanced Information
Descriptive Information
Brief Title  ICMJE 12 Week Open, Non-Comparative Switch Study Of Oral Ziprazidone In Previously Treated Schizophrenic Patients
Official Title  ICMJE 12 Week Open Label, Multicenter, Non-Comparative Switch Study Evaluating Efficacy, Tolerability And Safety Of Oral Ziprasidone In Treatment Of Patients Suffering From Schizophrenia Who Have Already Been Treated With An Other Antipsychotic.
Brief Summary There has been evidence that ziprasidone is efficacious in decreasing the magnitude of both positive and negative symptoms of schizophrenia, and also effective in the treatment of depressive symptoms. It shows good tolerance with low incidence of extrapyramidal side effects and does not significantly influence body weight. As it has been shown that ziprasidone is efficacious and safe in patients who have been pretreated with other antipsychotic that has to be withdrawn either due to the side effects or not satisfied efficacy. The purpose of the study was to provide further evidence for the efficacy and safety of patients with schizophrenia and allow for psychiatrists in Hungary to gain experience with the drug before wide commercial availability.
Detailed Description Study was terminated due to difficulty in enrolling the targeted number of patients on March 1, 2005, last subject last visit date was Feb.16, 2005. There were no safety concerns involved in the decision to terminate the trial.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE Drug: ziprazidone
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: September 11, 2005)		150
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE February 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • confirmed diagnosis of schizophrenia according to DSM-IV-IV from patient's medical files
  • subjects with current treatment with typical or atypical neuroleptics which should be changed

Exclusion Criteria:

  • patients with significant cardiovascular illness (recent acute myocardial infarction, uncompensated heart failure, cardiac arrhythmia)
  • in the patients' history clinically significant ECG abnormalities particularly prolongation of QT interval of more than 500 ms
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00159757
Other Study ID Numbers  ICMJE A1281122
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP